Norethindrone Acetate And Ethinyl Estradiol NDC 0378-7280

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-7280Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-7280Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0378-7280-53	00378728053	3 POUCH in 1 CARTON (0378-7280-53) / 1 BLISTER PACK in 1 POUCH (0378-7280-85) / 21 TABLET in 1 BLISTER PACKMarketed from Nov 7, 2014

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Norethindrone Acetate And Ethinyl Estradiol
Generic name (nonproprietary): norethindrone acetate and ethinyl estradiol
Active ingredients: Ethinyl estradiol — .02 mg/1Norethindrone acetate — 1 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202771
Marketing start: Jul 11, 2014
Listing expires: Dec 31, 2026
Other FDA classes: Estrogen Receptor Agonists (Mechanism)Progesterone Congeners (Chemical structure)
Identifiers: Product ID 0378-7280_e450353d-021c-b48d-d1ea-0787a1561ae2SPL ID e450353d-021c-b48d-d1ea-0787a1561ae2SPL set ID 89948751-bd6e-4e9c-b87c-8782706c1097RxCUI 1358762, 1358776UNII 423D2T571U, 9S44LIC7OJ
Pharmacologic class: Estrogen; Progestin

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N400378728053 followed by a unit qualifier and the quantity

Package 00378-7280-53. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 15, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Norethindrone acetate and ethinyl estradiol tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of methods can result in lower failure rates. TABLE I: LOWEST EXPECTED AND TYPICAL FAILURE RATES DURING THE FIRST YEAR OF CONTINUOUS USE OF A METHOD Adapted from RA Hatcher et al,…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 202771

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 202771
Product	Strength	Form · route	Labeler	Product NDC
Luizza 1/20norethindrone acetate and ethinyl estradiol	Ethinyl estradiol .02 mg/1; Norethindrone acetate 1 mg/1	TabletOral	Xiromed, LLC	70700-313